Alersis (desloratadin) oral solution 0.5 mg/ml. 60 ml. №1 vial

Description

Composition

active substance: desloratadine; 1 ml of solution contains desloratadine 0.5 mg;

auxiliary substances: sodium benzoate (E 211), sodium saccharin, sorbitol (E 420), propylene glycol, anhydrous citric acid, anhydrous sodium citrate, hydroxyethyl cellulose, orange flavoring, purified water.

Medicinal form Oral solution.

Pharmacotherapeutic group

Antihistamines for systemic use. ATX code R06A X27.

Pharmacodynamics.

Desloratadine is a powerful selective blocker of peripheral histamine H1 receptors, which does not have a sedative effect. Desloratadine is the primary active metabolite of loratadine.

After oral administration, Alersis selectively blocks peripheral H1-histamine receptors, since the drug almost does not penetrate through the blood-brain barrier.

Numerous studies have shown that, in addition to antihistamine activity, Allersis has demonstrated its anti-allergic and anti-inflammatory properties. It has been established that Allersis suppresses a cascade of various reactions that underlie allergic inflammation, namely:

• release of pro-inflammatory cytokines, including IL-4, IL-6, IL-8, IL-13;
• release of pro-inflammatory chemokines, such as RANTES;
• production of superoxide anion by activated polymorphonuclear neutrophils;
• adhesion and chemotaxis of eosinophils;
• expression of adhesion molecules, such as P-selectin;
• IgE-dependent release of histamine, prostaglandin D2 and leukotriene C4;
• acute allergic bronchospasm and allergic cough in animal studies.

The safety of the use of Alersis in children was demonstrated in three clinical studies. The drug was prescribed to children aged 6 months to 11 years who needed antihistamine therapy in a daily dose of 1 mg (age group from 6 to 11 months), 1.25 mg (age group from 1 to 5 years) or 2.5 mg (age group from 6 to 11 years). The treatment was well tolerated, which was confirmed by the results of clinical laboratory studies, the state of vital functions of the body and ECG data (including the length of the QT interval).

During clinical studies, the daily use of Alersis in a dose of up to 20 mg for 14 days was not accompanied by statistically clinically significant changes in the cardiovascular system. During a clinical and pharmacological study, the use of the drug at 45 mg/day (9 times higher than the therapeutic dose) for 10 days did not cause prolongation of the QT interval.

Desloratadine almost does not penetrate through the blood-brain barrier. When using the recommended dose of 5 mg, the frequency of drowsiness did not exceed that in the placebo group. In the course of clinical studies, Allersis did not affect psychomotor functions when taking a dose of up to 7.5 mg.

In addition to the accepted division of allergic rhinitis into seasonal and year-round, according to the duration of symptoms, allergic rhinitis can also be alternatively classified into intermittent and persistent. Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days per week or less than 4 weeks. In the case of persistent allergic rhinitis, symptoms are observed for 4 or more days per week or for a period of more than 4 weeks.

The clinical efficacy of Alersis in the treatment of seasonal allergic rhinitis was demonstrated in four placebo-controlled, multiple-dose clinical studies.

In patients with allergic rhinitis, Allersis effectively eliminated the following symptoms: sneezing, nasal discharge and itching, as well as eye irritation, tearing and redness, itchy palate.

Indication

To relieve symptoms associated with allergic rhinitis such as sneezing, runny nose, itching, swelling and nasal congestion, as well as itchy and red eyes, watery eyes, itchy palate and cough. To relieve symptoms associated with hives, such as itching and rashes.

Contraindication

Hypersensitivity to desloratadine, to any auxiliary component of the drug or to loratadine.

Dosage and Administration

To eliminate symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, Allersis can be used regardless of food intake in the following doses:

adults and adolescents (≥ 12 years): 10 ml of syrup (5 mg desloratadine) 1 time a day. Therapy of intermittent allergic rhinitis (presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the history data: stop after the disappearance of symptoms and resume after their re-emergence. With persistent allergic rhinitis (presence of symptoms more than 4 days a week or more than 4 weeks), it is necessary to continue the treatment during the entire period of contact with the allergen.

Children. The effectiveness and safety of the use of Alersys solution in children under 6 months of age have not been established. The drug is not recommended for children under 6 months of age for the treatment of chronic idiopathic urticaria and for children under 12 months of age for the treatment of allergic rhinitis.

The following dosage regimen is used for treatment:

• children aged 6 to 11 months: 2 ml of solution (1 mg desloratadine) once a day;
• aged from 1 to 5 years: 2.5 ml of solution (1.25 mg desloratadine) once a day;
• aged from 6 to 11 years: 5 ml of solution (2.5 mg desloratadine) once a day.